Mindfulness-Based Intervention for Pediatric Mild Traumatic Brain Injury

NCT07272941 | Not Yet Recruiting DMC

• 1 other identifier: 516950
• Study Type: interventional
• Target: 362
• Locations: 1 country
• Sites: 5

Brief Summary

Formal MBIs, such as Mindfulness-Based Stress Reduction (MBSR), have been shown to increase resiliency and teach affect regulation. However, these formal interventions may not be suitable for acutely concussed youth as they are costly, not easily accessible (trained therapists are needed), and require commitment from parents and children for in-person weekly meetings and at-home practice of learned skills for 8 to 16 weeks. Further, MBSR programs may not be readily accessible immediately after a concussion. With the increasing use of mobile phones and tablets in youth, mobile health offers a powerful platform for mental health interventions. Advantages of app-based interventions include constant availability, greater access, tailored content, lower cost, immediate delivery, and increased service capacity and efficiency. Therefore, the anticipated benefit is to show the efficacy of a pragmatic and low-cost intervention and reduce barriers to care through a novel, innovative and accessible MBI treatment program. This will have both a benefit to public health and expand our understanding of the impact of MBIs on pediatric recovery.

Conditions

Concussions; Mild Traumatic Brain Injury, Concussion; Concussion Mild

Keywords

mild traumatic brain injury; mtbi; concussion; intervention; meditation; quality of life; treatment; Persistent post-concussive symptoms; mindfulness

Outcome Measures

Primary Outcomes (1)

• Pediatric Quality of Life Inventory™ version 4.0

  The PedsQL is a reliable and valid measure of quality of life (QoL) in healthy children and adolescents and those with acute and/or chronic health conditions. Parent versions exist for children aged 2 to 18 years (in 4 age groups) and child versions for those aged 5 and over. For this study, only the child's version (ages 8-12 and ages 13-18) will be used. The inventory covers four domains: physical, emotional, social, and school, the sum of which is total QoL. This measure will be used to assess whether early brief MBI can improve total QoL. Higher scores indicate better health related to QoL.

  Day of enrolment (ED), Week 4, Week 8

Secondary Outcomes (12)

• Connor-Davidson Resilience Scale-10 (CD-RISC)

  Day 1, Week 4, & Week 8

• The 18-item PedsQL™ Multidimensional Fatigue Scale (PedsQL-MFS)

  Day 1, Week 4, & Week 8

• Health and Behaviour Inventory (HBI)

  Day of enrolment (ED; retrospective (parents) and post-injury (participant)), Week 2, Week 4, & Week 8

• The General Anxiety Disorder 7-items (GAD-7)

  Day of enrolment (ED), Week 4, & Week 8

• Center for Epidemiologic Studies Short Depression Scale (CES-D-10)

  Day of enrollment (ED), Week 4, & Week 8

Other Outcomes (4)

• Self assessments

  Daily through study completion, on average 8 weeks.

• Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTAQ)

  Week 1, Week 2, Week 4, Week 8

• Puberty Questionnaire

  Day of enrollment (ED)

Study Arms (2)

Mindfulness Intervention + Usual Care

EXPERIMENTAL

Experimental group: MBI training will consist of a 4-week custom-made program that includes setting intentions and check-in with mood, audio-recorded lectures, guided meditations such as body scans, and writing events journal. Each standardized course will be unlocked as the participant progresses through the program. Users will be encouraged to participate in the app-based activities for a total of 10-15 minutes every day, with a minimum of 4 days a week, over a period of 4 weeks (with the option to continue for 8 weeks).

Behavioral: Mindfulness Based Intervention (MBI)

Cognitive Sham + Usual care

SHAM COMPARATOR

Usual care recommends that patients refrain from physical and cognitive activities for 24-48 hours after concussion. After the initial rest period, it is recommended to introduce low to moderate levels of physical and cognitive activity at a level that does not result in recurrence or exacerbation of symptoms. Patients must refrain from any activities that increase the risk of re-injury (body contact or risk falls) until fully asymptomatic and cleared by their primary care or other medical provider. This arm is considered as active participant with the sham app (cognitive math game called "2048") delivered via the same app as the MBI, but without the mindfulness content. Participants will be encouraged to engage in the app-based activities for at least 10 minutes daily, with a minimum of 4 days per week, over a period of 4 weeks. Participants will also be asked questions about their stress, emotions, and symptoms.

Behavioral: Cognitive Sham

Interventions

Mindfulness Based Intervention (MBI) BEHAVIORAL

Using the Dawn MBI-based app, targeted MBI training will consist of a 4-to-8-week custom-made program that includes audio-recorded lectures, guided meditations such as walking meditations and body scans, setting intentions and check-in with mood, and writing events journal. Each standardized course is unlocked as the participant progresses through the MBI program. Participants will be encouraged to engage in the app-based activities for at least 10 minutes every day, with a minimum of 4 days per week, over a period of 4 weeks (with option to continue for 8 weeks).

Also known as: MBI, Dawn

Mindfulness Intervention + Usual Care

Cognitive Sham BEHAVIORAL

Usual care recommends that the patient refrain from physical and cognitive activities for 24-48 hours after injury. After the rest period, it is recommended that low to moderate levels of physical and cognitive activity be gradually started 24-48 hours after injury. The activities should be performed at a level that does not result in recurrence or exacerbation of symptoms. Children must refrain from any activities that increase the risk of re-injury (drills with body contact or that risk falls) until fully asymptomatic and cleared by their primary care or other medical provider. The sham journey will consist of playing an open-source cognitive math game (called "2048") delivered through the same app as MBI, but without the mindfulness content. Participants will be encouraged to utilize the app for at least 10 minutes every day, with a minimum of 4 days a week, over a period of 4 weeks.

Also known as: Usual Care

Cognitive Sham + Usual care

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participants presenting to five PERC EDs after sustaining a direct or indirect head injury
• Aged 12 through 17.99 years
• Diagnosed with a definite or suspected concussion, defined by the American College of Rehabilitation Medicine definition
• Score ≥6 on the 5P rule
• Suffered the index injury in the previous 48 hours
• Proficient in English or French

You may not qualify if:

• Glasgow Coma Scale ≤13
• Abnormality on standard neuroimaging studies, including positive head CT findings (Note: neuroimaging is not required, but may be performed if clinically indicated)
• Neurosurgical operative intervention, intubation or intensive care required
• Severe neurological developmental delay resulting in communication difficulties
• Intoxication at the time of ED presentation as per clinician judgment
• No clear history of trauma as primary events (e.g., seizure, syncope or migraine)
• Prior psychiatric hospitalization
• Inability to obtain a proper written informed consent/assent (language barrier, absence of parental authority, developmental delay, intoxication, patient too confused to consent, etc.)
• Legal guardian not present (certain forms need be completed by parents/legal guardians)
• No internet or mobile/tablet access.
• Previously enrolled in phase 1 or phase 2 of the feasibility trial or the efficacy trial.

Sponsors & Collaborators

• Children's Hospital of Eastern Ontario: lead
• The Hospital for Sick Children: collaborator
• Montreal Children's Hospital of the MUHC: collaborator
• University of Ottawa: collaborator
• British Columbia Children's Hospital: collaborator
• Stollery Children's Hospital: collaborator

Study Sites (5)

Stollery Children's Hospital

Edmonton, Ontario, T6G 2B7, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

The Hospital of Sick Children (SickKids)

Toronto, Ontario, M5G 1X8, Canada

Location

BC Children's Hospital

Vancouver, Ontario, V6H 3N1, Canada

Location

Montreal Children's Hospital

Montreal, H4A3H9, Canada

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Andrée-Anne Ledoux, PhD

  Children's Hospital of Eastern Ontario Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrée-Anne Ledoux, PhD

CONTACT

+1 613-737-7600; aledoux@cheo.on.ca

Tyrus Crawford

CONTACT

+1 613-737-7600; tcrawford@cheo.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Pragmatic-blinding
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist

Model Details: Pragmatic-blind randomized clinical trial with two two groups who will be studied: (1) experimental group: usual care plus early introduction of the app-based MBI; and (2) a delayed-start (crossover) control group: usual care plus early introduction sham application, including the cognitive math game called 2048, with option to receive experimental app-based MBI after 4 weeks.

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 9, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: March 18, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: These documents will be shared once the protocol is published
• Access Criteria: The protocol will be accessible online and through Trial.gov

Locations

CA (5)